A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
This study is looking at a new combination of two medicines, calderasib and pembrolizumab, for people with a type of lung cancer called non-small cell lung cancer (NSCLC). This is for patients whose cancer has a specific genetic change called KRAS G12C and a high level of a protein called PD-L1. The main goal is to see if giving calderasib together with pembrolizumab helps patients live longer or keeps their cancer from growing for a longer time, compared to giving pembrolizumab with a dummy drug (placebo). This is a late-stage study, meaning these treatments have been tested before and showed some promise. The hope is to find a more effective first treatment option for this specific group of lung cancer patients.
At a glance
What is this study about?
This study is about a type of lung cancer called non-small cell lung cancer, or NSCLC. This is the most common kind of lung cancer. Researchers are particularly interested in patients whose cancer has a specific genetic change, or mutation, called KRAS G12C, and also shows a high level of a protein called PD-L1. Finding these specific features in a patient's cancer helps doctors choose the best treatment.
The study is testing a new approach. It combines two medicines: calderasib and pembrolizumab. Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer. Calderasib is a newer drug designed to target the specific KRAS G12C gene change. The aim is to see if giving these two drugs together works better as a first treatment than giving pembrolizumab along with a dummy drug (placebo).
The main things the study wants to find out are whether the combination treatment helps people live longer and whether it stops the cancer from growing for a longer time. This type of study is important because it could lead to better treatment options for people with this specific type of lung cancer, potentially improving their health and quality of life.
Key takeaways
- This study is for a specific type of advanced non-small cell lung cancer.
- It tests a new combination of two medicines: calderasib and pembrolizumab.
- The goal is to see if this combination improves survival or prevents cancer growth.
- You will either get the new combination or a comparison treatment (pembrolizumab plus placebo).
- Regular health checks, blood tests, and scans will be part of the study.
- Participation involves commitment but also offers a potential new treatment option.
Who may be eligible?
To join this study, you generally need to have been diagnosed with non-small cell lung cancer that has spread to nearby areas or to other parts of your body, and your doctors believe that surgery or strong chemotherapy/radiation alone won't cure it. Your cancer must also have a specific genetic change called KRAS G12C and a high level of a protein called PD-L1, which will be checked from a recent or stored sample of your tumor tissue.
There are also some important health requirements. You should be generally well and if you've had side effects from previous cancer treatments, they need to have mostly gone away. Certain other serious health conditions, particularly active infections, severe heart problems, or some eye conditions, might mean you can't take part. If you have conditions like HIV or Hepatitis B/C, they need to be well-managed and under control.
This study is for adults aged 18 or older, and it's open to both men and women. The research team will carefully check all your medical information to make sure the study is a safe and suitable option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have advanced non-small cell lung cancer?
- Has my cancer been tested positive for the KRAS G12C gene change?
- Does my cancer show a high level of the PD-L1 protein?
- Are my other health conditions (like heart, liver, or infections) currently well-managed?
- Am I over 18 years old?
What does participation involve?
If you join this study, you would receive either the combination of calderasib and pembrolizumab, or pembrolizumab and a dummy pill (placebo). You wouldn't know which group you are in. You would take calderasib or the dummy pill every day, and pembrolizumab would be given through a drip (intravenous infusion) into your arm, usually every three weeks.
You would have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI scans) to see how you are doing and how the treatment is affecting your cancer. These visits would happen regularly over many months, and the total duration in the study could be quite long, continuing for as long as the treatment is helping you and you are tolerating it well. After stopping treatment, you would also have follow-up visits or calls to monitor your health.
Potential risks and benefits
Locations (222)
- CBCC Global Research, Inc. ( Site 0123)Verified postcodeBakersfield, United States· Recruiting
- Beverly Hills Cancer Center ( Site 0116)Verified postcodeBeverly Hills, United States· Recruiting
- Stamford Hospital ( Site 0136)Verified postcodeStamford, United States· Recruiting
- Mount Sinai Cancer Center ( Site 0137)Verified postcodeMiami Beach, United States· Completed
- Orchard Healthcare Research Inc. ( Site 0115)Verified postcodeSkokie, United States· Recruiting
- Truman Medical Center ( Site 0126)Verified postcodeKansas City, United States· Recruiting
- Cox Medical Center North ( Site 0133)Verified postcodeSpringfield, United States· Recruiting
- St. Vincent Frontier Cancer Center-Research ( Site 0105)Verified postcodeBillings, United States· Recruiting
- Atlantic Health System Morristown Medical Center ( Site 0121)Verified postcodeMorristown, United States· Recruiting
- New York Oncology Hematology, P.C. ( Site 0132)Verified postcodeAlbany, United States· Recruiting
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)Verified postcodeCincinnati, United States· Recruiting
- Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)Verified postcodeKettering, United States· Completed
Common questions
What is non-small cell lung cancer?
It's the most common type of lung cancer, and it's called 'non-small cell' because of how the cancer cells look under a microscope.
What does 'KRAS G12C mutation' mean?
This refers to a specific change in the genes of your cancer cells. Knowing this helps doctors choose certain treatments that target this change.
What is PD-L1?
PD-L1 is a protein your cancer cells might have. A high level of it can sometimes mean that certain immunotherapy drugs might work well for you.
What is a 'placebo'?
A placebo is a dummy pill or treatment that looks like the real medicine but contains no active drug. It helps researchers compare the real drug's effects.
Will I know if I'm getting the new combination treatment?
No, this is a 'blinded' study, meaning neither you nor your doctor will know if you are receiving the new combination or the comparison treatment. This helps ensure fair results.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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